Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

Twenty study centers in the United States of America participated. One of these did not enroll any participants.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

Participants, who were found eligible, were randomized to 1 of 3 groups in a 1:1:1 ratio between ACC-001 3 μg+QS-21, or ACC-001 10 μg+QS-21, or placebo (which was administrated as phosphate buffered saline [PBS]). The study randomization was stratified based on apolipoprotein E (Apo E) genotype (E4 carrier or non-carrier).

Reporting Groups

Description

ACC 3 μg+QS-21

Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.

ACC 10 μg+QS-21

Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.

Placebo

Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.

Participant Flow: Overall Study

ACC 3 μg+QS-21

ACC 10 μg+QS-21

Placebo

STARTED

22

20

21

Treated

22

20

21

Completed Treatment

21 [1]

18 [2]

17 [3]

COMPLETED

18 [4]

18 [4]

15 [4]

NOT COMPLETED

4

2

6

No Longer Willing to Participate

4

2

5

Participant moved to another town

0

0

1

[1]

1 participant discontinued treatment due to an adverse event (AE).

[2]

2 participants discontinued treatment due to no longer willing to participate in study.

[3]

1 participant stopped treatment due to lack of efficacy, 3 due to no longer willing to participate.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

ACC 3 μg+QS-21

Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.

ACC 10 μg+QS-21

Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.

Placebo

Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.

Total

Total of all reporting groups

Baseline Measures

ACC 3 μg+QS-21

ACC 10 μg+QS-21

Placebo

Total

Overall Participants Analyzed [Units: Participants]

22

20

21

63

Age [Units: Years]Mean (Standard Deviation)

66.8 (7.31)

68.5 (7.02)

69.6 (6.82)

68.3 (7.04)

Gender [Units: Participants]

Female

11

13

9

33

Male

11

7

12

30

MMSE Score [1] [Units: Score]Mean (Standard Deviation)

27.3 (1.64)

27.7 (1.63)

28.0 (1.47)

27.6 (1.58)

[1]

The MMSE is a brief, structured examination of cognitive function consisting of the 11 item: Orientation-What, Orientation-Where, Registration-Objects, Attention and Calculation, Recall, Language-Naming, Language-Repetition, Language-Comprehension, Language-Reading, Language-Writing, and Language- Drawing. MMSE total score was the sum of the 11 item scores and it ranges from 0 to 30 with higher score indicating greater cognitive functioning. If any individual item is missing, then the MMSE total score is set to missing.

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is less than or equal to 60 days.
The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is more than 60 days but less than
or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Restriction Description:
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.